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EC number: 240-354-5 | CAS number: 16230-35-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 20, 2017 - February 27, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature. - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: sampling at day 0 and 5.
- Buffers:
- - pH: 4, 7 and 9
- Type and final molarity of buffer: Buffer solution from Avantor Performance Materials Poland S.A. (formerly POCh S.A) for calibration of pH electrode and for determination of the hydrolysis rate constants.
0,8032 g of V-BA was weighed and dissolved in 10 mL of acetone (about 73.02 g/L). The portions of 0.5 mL of this obtained stock V-BA solution was added to each of 49.5 mL of the three buffer solutions (pH values: 4.0; 7.0 and 9.0). The obtained initial test item concentration, in the buffer solutions, should have achieved about 0.73 g/L of test item or 0.63 g/l of N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide], which is 0.002 M (less than 0.01 M). - Estimation method (if used):
- The rate constant can be calculated using the Arrhenius equation, which gives the temperature dependence of the rate constant. From the linear plot of the logarithm of the rate constant, as determined at appropriate temperature, as a function of the reciprocal of the absolute temperature [K], it is possible to extrapolate the rate constant value which was not directly obtainable.
- Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: glass flasks fitted with glass stoppers; analytical balance WAS 220/C/2, accuracy of readings ± 0.1 mg; incubator; laboratory centrifuge MPW-350 RH; laboratory multifunctional device CX-505, accuracy of readings ± 0.01 pH; magnetic stirrer.
TEST MEDIUM
- Volume used/treatment: 25 mL
- Preparation of test medium: 0.50 ml of tested samples, withdrawn from the buffer solutions, were added to 25.0 ml of acetonitrile, and were directly injected into the HPLC column.0,8032 g of V-BA was weighed and dissolved in 10 mL of acetone (about 73.02 g/L). The portions of 0.5 mL of this obtained stock V-BA solution was added to each of 49.5 mL of the three buffer solutions (pH values: 4.0; 7.0 and 9.0). The obtained initial test item concentration, in the buffer solutions, should have achieved about 0.73 g/L of test item or 0.63 g/l of N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide], which is 0.002 M. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 0.583 g/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 0.587 g/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 0.609 g/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The preliminary test indicates that less than 10% of the test substance has been hydrolyzed after five days at pH 4, 7 and 9 and no additional testing is required.
- Transformation products:
- no
- % Recovery:
- 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 99.01
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Key result
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes - Validity criteria fulfilled:
- yes
- Remarks:
- Selectivity: equivalent; Linearity R2= 0.9971 (R2≥0.99); Precision 0.0106 mg/mL, RSD= 1.13% (RSDr ≤ 7.58%); Precision of the repeatibility RSD= 1.12% (RSDr ≤ 1.37%)
- Conclusions:
- The test item hydrolysed less than 10% after 5 days at pH of 4, 7 and 9. Then, the test item is considered hydrolytically stable.
- Executive summary:
A hydrolysis study of the test item as a function of pH was performed according to OECD 111, following GLP. A preliminary test (Tier 1) was conducted at pH 4.0, 7.0 and 9.0 at 50ºC in the darkness. A validated HPLC method was used to determine the amount of test item in the samples. All the validity criteria were met. In the preliminary test, less than 10% of the test item has been hydrolyzed after five days. Therefore, according to the OECD guidelines, this substance is considered hydrolytically stable and no additional testing is required.
Reference
Determination ofV-BA contentin buffer solutions of pH 4, pH 7 and pH 9.
Table 1: Calibration solution
Weight [mg] |
Dilution [mL] |
Cw [mg/mL] |
Peak area |
Average peak area Aw |
f×103 |
Average f × 103 |
|
35.25 |
25-0.8-25-2.5-5 |
0.01918 |
674477 |
656831 |
665654.0 |
0.000029 |
0.000027 |
42.65 |
25-0.6-25-2.5-5 |
0.01740 |
704530 |
708223 |
706376.5 |
0.000025 |
Table 2. Study solution
Sample day/ flask |
Peak area |
Average peak area Ap |
X [g/kg] |
||
0
|
pH4-1 |
429479 |
439905 |
434692 |
0.5808 |
pH4-2 |
435635 |
439054 |
437344.5 |
0.5843 |
|
pH7-1 |
437353 |
463677 |
450515 |
0.6019 |
|
pH7-2 |
423294 |
431463 |
427378.5 |
0.5710 |
|
pH9-1 |
459756 |
459891 |
459823.5 |
0.6143 |
|
pH9-2 |
455873 |
447313 |
451593 |
0.6034 |
|
VERNETZER/AC* |
1208548 |
1202731 |
1205639.5 |
63.11 |
|
5 |
pH4-3 |
432763 |
444997 |
438880 |
0.5864 |
pH4-4 |
452024 |
450440 |
451232 |
0.6029 |
|
pH7-3 |
462883 |
468207 |
465545 |
0.6220 |
|
pH7-4 |
469782 |
474093 |
471937.5 |
0.6305 |
|
pH9-3 |
469715 |
468459 |
469087 |
0.6267 |
|
pH9-4 |
440436 |
427442 |
433939 |
0.5798 |
*VERNETZER/AC: weighed amount of N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide in acetone stock solution.
Table 3.Measurements in buffer solution at pH 4.0
Time, days |
0 |
5 |
|
concentration, [g/L] |
1 flask |
0.5808 |
0.5864 |
2 flask |
0.5843 |
0.6029 |
|
average concentration, [g/L] |
0.583 ± 0.003 |
0.595 ± 0.012 |
|
concentration loss, [%] |
-2.06 |
Table 4.Measurements in buffer solution at pH 7.0
Time, days |
0 |
5 |
|
concentration, [g/L] |
1 flask |
0.6019 |
0.6220 |
2 flask |
0.5710 |
0.6305 |
|
average concentration, [g/L] |
0.587 ± 0.022 |
0.626 ± 0.006 |
|
concentration loss, [%] |
-6.64 |
The increase in N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide] concentration – negative value of concentration loss - after 5 days results from the used analytical method properties: possible solvent vaporization, non ideal volumes withdrawals etc.
The obtained negative concentration loss should be assumed to be close to 0.0%.
Table 5.Measurements in buffer solution at pH 9.0
Time, days |
0 |
5 |
|
concentration, [g/L] |
1 flask |
0.6143 |
0.6267 |
2 flask |
0.6034 |
0.5798 |
|
average concentration, [g/L] |
0.609 ± 0.008 |
0.603 ± 0.033 |
|
concentration loss, [%] |
0.99% |
Description of key information
Key study: OECD 111. GLP study. The test item hydrolysed less than 10% after 5 days at pH of 4, 7 and 9. Then, the test item is considered hydrolytically stable.
Key value for chemical safety assessment
Additional information
Key study: A hydrolysis study of the test item as a function of pH was performed according to OECD 111, following GLP. A preliminary test (Tier 1) was conducted at pH 4.0, 7.0 and 9.0 at 50ºC in the darkness. A validated HPLC method was used to determine the amount of test item in the samples. All the validity criteria were met. In the preliminary test, less than 10% of the test item has been hydrolyzed after five days. Therefore, according to the OECD guidelines, this substance is considered hydrolytically stable and no additional testing is required.
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